LAS VEGAS, NV — Larry Dillaha, MD, of INSYS Therapeutics, Phoenix, AZ, and colleagues reported at PAINWeek 2012 that fentanyl sublingual spray markedly improved satisfaction with symptom relief among patients with breakthrough cancer pain (BTCP).

Patients who experience BTCP have decreased satisfaction with around-the-clock opioid therapy. This analysis examined patient satisfaction with a sublingual formulation of fentanyl, fentanyl sublingual spray.

The study involved an open-label titration phase and a randomized, placebo-controlled study, and it included opioid-tolerant patients with 1–4 episodes of BTCP per day. The 26-day, open-label titration phase (n=130) established a successful dose of 100mcg to 1,600mcg that provided effective analgesia for two consecutive BTCP episodes. During the 26-day, double-blind phase (n=95), patients received 7 units of study medication and 3 units of placebo, and the global evaluation of study medication was performed at 30 and 60 minutes postdose.

All domains of the Treatment Satisfaction Questionnaire for Medication increased from baseline to the end of titration, with the greatest improvements occurring for effectiveness (mean [SE]: 48.8 [1.6] to 75.2 [1.4]) and global satisfaction (55.1 [1.9] to 75.4 [1.7]). The satisfaction of the patients with the effectiveness, meaning onset of action, improved from 21.1% with previous BTCP medication to 89.5% with fentanyl sublingual spray. Mean global evaluation scores improved at both 30 and 60 minutes with fentanyl sublingual spray vs. placebo (P<0.0001).


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Dr. Dillaha and colleagues noted that one or more adverse events (AEs) were experienced by 78 patients (60.0%) during titration and 47 patients (48.9%) during double-blind treatment.  During titration, nausea (13.1%) and somnolence (8.5%) were common AEs, while nausea (7.1%), peripheral edema (5.1%), and hyperhidrosis (5.1%) were common AEs during double-blind treatment. Severity was mild or moderate for most (88%) AEs.